Senior Manager, Patient Safety and Pharmacovigilance Quality

• Monitor global regulatory requirements, procedures, and guidance (e.g., ICH, FDA, EMA, MHRA, TGA, and ICH-GCP/ICH-E2E guidelines, etc.) and assess impact on existing procedures and recommending updates
• Develop and maintain quality metrics for PSPV operations (e.g., SAE case reconciliation, inline and retrospective ICSR review, etc.)
• Identify process gaps and develop stage-appropriate solutions within PSPV and the safety vendor
• Support the development and maintenance of PSPV departmental Key Performance Indicators (KPI), Key Quality Indicators (KQIs), and monthly compliance metrics
• Develop and implement processes for the management of all PSPV procedures and controlled documents (e.g., Policies, SOPs, WIs)
• Track PV deviations, compliance issues, or other quality events
• Contribute to CAPA development, review, monitor, and trend root cause analyses and propose preventive actions
• Partner with Quality Assurance and other key stakeholders and provide PSPV input into organizational initiatives (e.g. quality monitoring, system implementations/improvements, process changes, inspection readiness)
• Contribute to the maintenance of PSPV Pharmacovigilance Agreements
• Support PSPV document review activities (e.g., signal detection, DSUR, risk management plans, literature review, etc.)
• Maintain inspection readiness for PSPV activities, including support for audits and health authority inspections
• Support TMF filing activities
• Track PSPV commitments from internal audits, regulatory inspection findings, safety vendor non-compliance, and CAPAs
• Provide PSPV compliance training to internal and external teams
• Promote a culture of compliance, operational excellence, and continuous improvement within the PSPV team and cross-functionally
• Drive and/or support initiatives to standardize procedures, improve efficiency, and manage change within PSPV operations
• Participate in PSPV and cross-functional team meetings and in vendor governance activities (e.g., KPI review, quality metrics, deviation tracking, etc.)
• Other activities/responsibilities as required

• Minimum of 8+ years of experience in Drug Safety/Pharmacovigilance (specifically, PV quality and compliance, and/or operations) within the pharmaceutical or biotechnology industry
• Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP, GxP)
• Demonstrated experience in audits/inspections, quality investigations, or CAPA management
• Proven ability to identify issues, analyze root causes, propose, and implement effective solutions
• Strong organizational, time management, and project prioritization skills, including excellent verbal and written communication and interpersonal skills, and proficient computer skills, including Microsoft Word and Excel
• Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment, and adaptable to changing priorities
• Must be able and willing to travel on occasion
• Bachelor’s degree in Life Sciences (or equivalent experience) or a related field required. (BS, RN, preferred)

Prior PV quality and compliance and vendor management experience preferred

• comprehensive health coverage
• flexible time off
• paid holidays
• year-end shutdown
• monthly wellness stipend
• generous 401(k) match
• tuition reimbursement
• commuter benefits
• disability and life insurance
• annual bonus opportunities
• equity grants